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21 Mar 2020

US FDA halts the regular plant inspection due to Covid-19 spread

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The US FDA announced that it will no longer be able to inspect domestic production facilities in wake of risk posed by the continuing spreading of novel coronavirus across the globe and the agency calls for industry to own product quality. 483 observation and warning letter

US health regulator states that the decision to halt domestic inspection was made for the health and well-being of the agency’s staff and family members, as well as concerns expressed by the industry over the visitors to the faciliites.

At first, the inspection will be suspended for all non-US facilities. Now, the US health regulator is dialing back on domestic facility inspections. In the wake of novel coronavirus (COVID-19 continues to spread, many companies and organizations are encouraging their employees to work remotely. This also applies to a number of US regulatory bodies, including the US Food and Drug Administration. On March 18, 2020 the US FDA announced that due to many of its employees working remotely, it would be postponing routine inspections of American manufacturing facilities.

In fact, inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products, however inspections are not what cause quality to happen. Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products.

In 2019, the US FDA conducted almost 12,300 inspections in the country across a variety of healthcare product categories, including drugs, medical devices, cosmetics, veterinary products, and more. However, the agency has decided to halt inspections due to safety concerns regarding its employees as well as preventing the potential spread of COVID-19. It will still conduct inspections it considers to be “mission critical.”

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